R&D Submission Documents Package

QUMAS offers a number of Packaged Solutions providing
pre-defined and pre-tested configurations of Document
content management or Process management for specific,
common industry problems. This Package addresses
document management requirements around documents
used in Global Regulatory Submissions, particularly CTD and
eCTD submissions. The pre-defined configuration supports
the creation, approval, and ongoing lifecycle management
of documents used in functions such as Clinical, Nonclinical,
Quality, Manufacturing, Regulatory Affairs, and Safety.

Package features

The R&D Submission Documents package offers the QUMAS DocCompliance application, together with a pre-defined configuration to support development of documentation used in submissions to global regulatory authorities.

This package contains advanced, out-of-the-box EDMS functionality including the following features:

• Audit trails
• Reporting
• Workflows
• Messaging
• Auto-rendering
• Version control
• Lifecycle management
• Full-text searching
• Role-based security / permissions
• 21 CFR Part 11 electronic signatures

This package also contains the following pre-defined configurations and professional services:

1) DocCompliance configuration, designed specifically for R&D use, based on business fundamentals following the DIA EDM reference model and CTD standards. Features include:

• 15 pre-defined document types, including the following:CMC – drug product, CMC – drug substance, specifications, site / clinical study, nonclinical, regional (i.e., module 1), safety, submission archive, and product information
• Seven pre-defined workflows to ensure best practice content progression and management
• Four pre-defined collection types: CSR, CTMF, CTD and general collections
• A taxonomy (cabinet / folder structure) matching the common CTD structure
• Supporting configuration for R&D submissions

2) Documentation, including:

• Design Document detailing the pre-defined configuration
• Client-specific Picklist values document (to be filled in by client and returned to QUMAS for inclusion in
• configuration prior to installation)
• Validation Pack: IQ, PQ, functional specification, design specification, and trace matrix (OQ not required because this package contains a pre-defined configuration)
• End-user training course (PDF guide) plus 90-days access to QUMAS’ bomputer-based training (CBT) series
• System access plan (to be filled in by client and returned to QUMAS for inclusion)

3) Professional services including full package installation, delivery of end-user training and train-the-trainer training

4) A Professional services review once the system has been in production use for at least three months

Package benefits

The R&D Submission Documents package provides:

• Industry standard design mapped to DIA EDM model for document types, attributes and taxonomy
• The ability to store an archive of submissions and correspondence with agencies
• Pre-defined configuration
• Complete documentation, IQ/PQ test scripts and end-user training
• Complete installation and design services documented and performed by QUMAS
• Fully understood and proven implementation methodology for successful project delivery
• Lifecycle management of regulatory submission source documents
• Electronic archiving of final submissions and agency correspondence

The Package design allows authorized users to create a variety of documents intended for drug submission, or to import them from external sources, control access to them by group membership and approve them with 21 CFR Part 11 compliant electronic signatures, if applicable. Documents can be printed, edited, and approved, as well as scheduled for automated periodic reviews. All actions are captured in the audit trail.

QUMAS has over 15 years of experience in delivering Compliance Solutions for regulated industries. From this experience, a common, industry standard design has been developed and tested, providing a pre-defined configuration of document types and minimum attribute sets, fully supported by workflows for editing, approving, re-approving and retiring documents, a controlled printing system and all supporting documentation and professional services for installation, testing and training.

Additional options

In addition to the out-of-the-box elements of this package, clients have the option to purchase further options such as:

• Additional training days (end user and / or system administrator)
• Additional specific configuration (together with the required documentation, tests, and training)
• Integrations to other systems (e.g., learning management system)
• Custom reports
• Computer-based training (CBT)
• Import application for batch import of documents
• CTD document template set (ISI Writer)

System Requirements

• Four servers for each of two environments (validation and production)
• Database server
• Web server
• Render server
• Autopopulate
• Servers can either be physical or virtual hardware
• Detailed guidance on system specifications is available
• Servers can be shared for multiple QUMAS packages